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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE HORIZONTAL SPAR, HIP DISTRACTOR APPARATUS, TRACTION, NON-POWERED

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STRYKER ENDOSCOPY-SAN JOSE HORIZONTAL SPAR, HIP DISTRACTOR APPARATUS, TRACTION, NON-POWERED Back to Search Results
Catalog Number 3105000104
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2020
Event Type  Injury  
Manufacturer Narrative
Additional information will be provided once the investigation has been completed. The device manufacturer date is not known at this time. However, should it become available it will be provided in future reports.
 
Event Description
It was reported that part of the procedure was postponed per the surgeon's decision. Please note there was no patient harm.
 
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Brand NameHORIZONTAL SPAR, HIP DISTRACTOR
Type of DeviceAPPARATUS, TRACTION, NON-POWERED
Manufacturer (Section D)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer (Section G)
STRYKER ENDOSCOPY-SAN JOSE
5900 optical court
san jose CA 95138
Manufacturer Contact
andrea zenere
5900 optical court
san jose, CA 95138
4087542000
MDR Report Key10782141
MDR Text Key214517272
Report Number0002936485-2020-00450
Device Sequence Number1
Product Code HST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number3105000104
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 11/03/2020 Patient Sequence Number: 1
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